ZOLBETUXIMAB
Information current as at: 1 July 2026
PBAC meeting date: November 2026
Submission Details
- Brand name:
-
- Vyloy®
- Form and strength:
-
- Powder for I.V. infusion 300 mg (6 mg per mL)
- Submission sponsor:
- ASTELLAS PHARMA AUSTRALIA PTY LTD
- Condition/indication:
(therapeutic use) -
- Gastric or gastroesophageal junction (G/GOJ) cancer
- Listing requested:
- To request listing of a new form of zolbetuximab (in combination with platinum-based chemotherapy plus a fluoropyrimidine drug) for the first-line treatment of patients with locally advanced, unresectable or metastatic epidermal growth factor receptor 2-negative G/GOJ cancer. The 100 mg injection vial was previously recommended by the PBAC at its September 2025 meeting.
- Funding program:
- PBS Section 100 (Efficient Funding of Chemotherapy)
- Request authority level:
- Authority Required (STREAMLINED)
- PBAC Submission type:
- New PBS listing (–)
- Comment:
- --
- Other PBAC consideration:
- --
Progress Details
-
Submission received for: - November 2026 PBAC meeting
-
2Opportunity for consumer comment:
- Open 22/07/2026 and close 16/09/2026 (see PBS Website)
-
3PBAC meeting:
- Has not yet occurred
-
4PBAC outcome published:
- Pending PBAC outcome (see PBAC Outcomes)
-
5Lodgement of required documentation:
-
6Agreement to listing arrangements:
- Has not yet commenced
-
7Government processes:
- Has not yet commenced
-
8Medicine listed on the PBS:
- Has not yet occurred
PBAC Outcome
Case ID
a1316
Page last updated
23 July 2026
v.9.19